Annual Product Review (APR) MCQs With Answer

Introduction: Annual Product Review (APR) MCQs With Answer

The Annual Product Review (also called Product Quality Review or PQR in some regions) is a fundamental quality system activity that evaluates the consistency and control of a marketed pharmaceutical product over a defined period. This blog provides M.Pharm students with focused multiple-choice questions to deepen understanding of APR objectives, data sources, trending, regulatory expectations, root-cause analysis, CAPA, and documentation practices. Each question emphasizes practical knowledge needed for preparing, reviewing, and acting on APR findings, including statistical tools, stability data interpretation, out-of-specification trends, and interdepartmental responsibilities. These MCQs will help reinforce concepts used in GMP compliance and quality management system audits.

Q1. What is the primary objective of an Annual Product Review (APR)?

• To replace routine batch release testing
• To summarize manufacturing performance and ensure ongoing product quality
• To document raw material supplier audits
• To plan annual marketing strategies

Correct Answer: To summarize manufacturing performance and ensure ongoing product quality

Q2. Which of the following data sources is NOT typically included in an APR?

• Batch production records and deviations
• Stability study results
• Marketing sales forecasts
• Customer complaints and returns

Correct Answer: Marketing sales forecasts

Q3. How often should an APR be prepared for each marketed product under common GMP expectations?

• Weekly
• Monthly
• Annually
• Only after major changes

Correct Answer: Annually

Q4. Which metric is most relevant for assessing manufacturing yield trends in an APR?

• Complaint response time
• Overall yield percentage and reject rates
• Number of SOPs updated
• Sales revenue per batch

Correct Answer: Overall yield percentage and reject rates

Q5. When an APR identifies a recurring out-of-specification (OOS) result trend, the most appropriate next step is:

• Ignore it if within annual average
• Initiate root cause investigation and CAPA
• Increase sampling to mask the trend
• Delete older batches from the dataset

Correct Answer: Initiate root cause investigation and CAPA

Q6. Which statistical tool is commonly used in APRs for trending process data?

• Survival analysis
• Control charts (e.g., X-bar and R charts)
• ANOVA for marketing segments
• Kaplan-Meier plots

Correct Answer: Control charts (e.g., X-bar and R charts)

Q7. APR scope should typically cover which of the following time frames for stability data review?

• Only initial release stability points
• Full available stability dataset up to the review date
• Only accelerated stability data
• Only stability data from failed batches

Correct Answer: Full available stability dataset up to the review date

Q8. Which regulatory guidance commonly expects firms to perform regular product quality reviews or APRs?

• Guidance for Clinical Trial Design
• Good Manufacturing Practice (GMP) guidance from authorities like EMA/WHO
• Advertising and Promotion Guidelines
• Tax regulations for pharmaceutical companies

Correct Answer: Good Manufacturing Practice (GMP) guidance from authorities like EMA/WHO

Q9. In an APR, how should changes introduced during the year (e.g., process or site changes) be documented?

• They should be excluded to keep the dataset homogeneous
• Documented with justification, impact assessment, and linked change control records
• Only verbal notes in the review meeting minutes
• Listed without supporting evidence

Correct Answer: Documented with justification, impact assessment, and linked change control records

Q10. Which of the following is a critical quality attribute to monitor in an APR for a solid oral dosage form?

• Tablet weight variation, assay (potency), and dissolution
• Number of marketing brochures printed
• Employee satisfaction scores
• Warehouse lighting levels

Correct Answer: Tablet weight variation, assay (potency), and dissolution

Q11. Who is usually responsible for compiling and authorizing the APR within a pharmaceutical company?

• Marketing manager alone
• Quality unit or designated quality reviewer with cross-functional inputs
• External auditors only
• Production line operators without review

Correct Answer: Quality unit or designated quality reviewer with cross-functional inputs

Q12. How should APR findings that indicate a significant trend be handled in terms of documentation?

• Document trends, corrective actions, effectiveness checks, and timelines
• Note verbally and act informally
• Delay documentation until the next year
• Only record positive findings

Correct Answer: Document trends, corrective actions, effectiveness checks, and timelines

Q13. When selecting batches for inclusion in an APR, the best practice is to:

• Include all batches manufactured and released during the review period
• Select only the best-performing batches
• Include only batches from the busiest months
• Exclude clinical trial batches by default without assessment

Correct Answer: Include all batches manufactured and released during the review period

Q14. How is the APR different from routine batch release documentation?

• APR is a periodic, holistic review of trends; batch release is batch-by-batch conformance verification
• APR replaces batch release testing
• APR focuses only on marketing aspects
• There is no difference

Correct Answer: APR is a periodic, holistic review of trends; batch release is batch-by-batch conformance verification

Q15. Which of the following should be included as part of the APR’s evaluation of supplier performance?

• Supplier audit results, nonconformances, and material quality trends
• Supplier corporate logo designs
• Supplier marketing budgets
• Supplier office locations only

Correct Answer: Supplier audit results, nonconformances, and material quality trends

Q16. If stability data show a small but consistent decline in assay near shelf life, the APR should:

• Ignore it if all batches still meet specification at release
• Assess potential root causes, consider re-evaluating shelf life or packaging, and initiate CAPA if needed
• Immediately withdraw all marketed batches without investigation
• Adjust acceptance criteria to accommodate decline

Correct Answer: Assess potential root causes, consider re-evaluating shelf life or packaging, and initiate CAPA if needed

Q17. Which performance indicator in an APR would directly reflect the effectiveness of corrective actions taken during the year?

• Reduction in recurrence of specific deviations or OOS incidents
• Number of employees hired
• Volume of promotional material distributed
• Frequency of company social events

Correct Answer: Reduction in recurrence of specific deviations or OOS incidents

Q18. How should customer complaints and recall data be treated in an APR?

• Ignored unless they lead to regulatory action
• Analyzed for trends, severity, root cause, and linked to CAPA and risk mitigation
• Filed separately with no cross-reference
• Only summarized as numbers without analysis

Correct Answer: Analyzed for trends, severity, root cause, and linked to CAPA and risk mitigation

Q19. Which statement best describes the relationship between APR and a pharmaceutical quality system like ICH Q10?

• APR is unrelated to quality systems
• APR is a core output of an effective pharmaceutical quality system and supports continual improvement
• APR replaces the need for a quality manual
• APR is only a marketing requirement

Correct Answer: APR is a core output of an effective pharmaceutical quality system and supports continual improvement

Q20. What is the appropriate way to handle confidential commercial data when preparing an APR for regulatory inspection?

• Omit the APR entirely from inspection packs
• Provide a redacted or summarized version as agreed with regulatory authorities while retaining full records internally
• Publish full commercial data publicly
• Refuse to provide any information

Correct Answer: Provide a redacted or summarized version as agreed with regulatory authorities while retaining full records internally

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